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Transcranial Current Stimulation as a Treatment for Auditory Hallucinations in Schizophrenia

Not Applicable
Completed
Conditions
Schizophrenia
Auditory Hallucinations
Schizoaffective Disorder
Interventions
Device: tDCS
Device: Sham stimulation
Registration Number
NCT01963676
Lead Sponsor
University of North Carolina, Chapel Hill
Brief Summary

Investigating the effect of non-invasive transcranial current stimulation on auditory hallucinations in patients with schizophrenia. Normal neuronal activity is perturbed in schizophrenia, so selective targeting of this abnormal activity could serve as a treatment for schizophrenia and alleviate symptoms caused by abnormal neuronal activity, such as auditory hallucinations.

Detailed Description

AIM 1: To evaluate the effect of transcranial direct current stimulation (tDCS) (2mA for 20min on five consecutive days) on auditory hallucinations in schizophrenia patients using the change in ratings on the Auditory Hallucination Rating Scale (AHRS) by patients before and after stimulation. We hypothesize that tDCS will modulate the abnormal neuronal activity found in schizophrenic patients and thereby decrease their auditory hallucinations when measured after stimulation.

AIM 2: To evaluate the long term effects of tDCS by having patients give a rating on the AHRS after one month has passed since stimulation and comparing this value to their baseline score and their score immediately after stimulation. We hypothesize that there will remain a significant reduction in auditory hallucination score in participants who received tDCS at one month.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
26
Inclusion Criteria
  • Diagnostic and Statistical Manual IV (DSM-IV) diagnosis of schizophrenia, any subtype, or schizoaffective disorder, with refractory auditory hallucinations. Duration of illness >1 year.
  • 18-99 years old.
  • Clinically stable for at least 12 weeks, i.e. not requiring hospitalization or a change in level of care .
  • On current antipsychotic doses for approximately 4 weeks or more.
  • Capacity to understand all relevant risks and potential benefits of the study (informed consent) OR has a legal guardian who can complete consent forms on the patients behalf
  • Right handed
Exclusion Criteria
  • Subjects with a DSM-IV diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months.
  • History of significant head injury/trauma, as defined by loss of consciousness for more than 1 hour, or recurring seizures, or requiring later cognitive rehabilitation or causing cognitive sequelae.
  • Prior brain surgery.
  • Any brain devices/implants, including cochlear implants and aneurysm clips.
  • Co-morbid neurological condition (i.e. seizure disorder, brain tumor).
  • Medical or neurological illness (unstable cardiac disease AIDS, malignancy, liver or renal impairment) or treatment for a medical disorder that could interfere with study participation.
  • Non English speakers.
  • Pregnancy, nursing, or if female and fertile, unwilling to use appropriate birth control measures during study participation

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
transcranial direct current stimulation (tDCS)tDCS13 subjects total. 2mA stimulation for 20 minutes.
Sham stimulationSham stimulation13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.
Primary Outcome Measures
NameTimeMethod
Change in Auditory Hallucination Rating Scale (AHRS)Score From Baseline to Day 5Baseline, Day 5

Examining AHRS total score after 5 days of stimulation compared to baseline assessment total.

Secondary Outcome Measures
NameTimeMethod
Persistence of Decrease in AHRS Score Over TimeDay 5, One month

We will re-assess patients one month after the completion of stimulation to evaluate whether their change from baseline to day 5 score on the AHRS persisted over time, namely 30 days.

Trial Locations

Locations (2)

University of North Carolina at Chapel Hill, Outpatient STEP Clinic

🇺🇸

Chapel Hill, North Carolina, United States

University of North Carolina, Wake STEP Clinic

🇺🇸

Raleigh, North Carolina, United States

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